RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026CARDINAL HEALTH CANADA INC.Official source

    Cardinal Health surgical gowns recall in Canada: Packaging defect

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    In plain language

    This recall involves various Cardinal Health surgical gowns sold in Canada. They are being recalled because of potential open packaging seals, which could compromise sterility. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact Cardinal Health Canada Inc. if you require additional information.

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    Affected products

    • SMARTGOWN™ BREATHABLE SURGICAL GOWNS WITH RAGLAN SLEEVES

      Model: 32474, A32474, A9041EL, C32474

      Lot: More than 10 numbers, contact manufacturer.

    • SMARTSLEEVE™ POLY-REINFORCED BREATHABLE SLEEVE SURGICAL GOWNS

      Model: 9011, A9011

      Lot: More than 10 numbers, contact manufacturer.

    • CARDINAL HEALTH™ POLY-REINFORCED SURGICAL GOWNS

      Model: A9070, A9070N

      Lot: 21CKQ001, 21CKQ002, 21HKQ001

    • ROYALSILK® NON-REINFORCED SURGICAL GOWNS

      Model: A9518, A9548, A9578, A95998

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Compromised sterility due to open packaging seals

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: 21CKQ001, 21CKQ002, 21HKQ001, More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 32474, 9011, A32474, A9011, A9041EL, A9070, A9070N, A9518, A9548, A9578, A95998, C32474

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    Compromised sterility due to open packaging seals

    What should consumers do?

    Stop using the product immediately. Contact Cardinal Health Canada Inc. if you require additional information.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    Yes, there may be a health risk. Compromised sterility due to open packaging seals

    When was this product recalled?

    This product was recalled on November 19, 2021.

    Is the CARDINAL HEALTH CANADA INC. brand affected by this recall?

    Yes, CARDINAL HEALTH CANADA INC. products are affected by this recall. This recall involves various Cardinal Health surgical gowns sold in Canada. They are being recalled because of potential open packaging seals, which could compromise sterility. Stop using the product and contact the manufacturer for more information.